BEUDAMED
    FDA Adverse Event Other Summary report: N

    RNA MEDICAL HEMATOCRIT CONTROL LEVEL 3

    MDR report key: 706787 · Received May 1, 2006

    Report

    Report Number
    1220649-2006-00001
    Event Type
    Other
    Date Received
    May 1, 2006
    Date of Event
    March 30, 2006
    Report Date
    April 24, 2006
    Manufacturer
    BIONOSTICS, INC.
    Product Code
    CGA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CUT HER FINGER AFTER SNAPPING OPEN A GLASS AMPOULE OF CONTROL MATERIAL A PER DIRECTIONS FOR USE. AS A RESULT OF THIS INJURY THIS PERSON REQUIRED STITCHES AND WAS GIVEN A TETANUS BOOSTER INOCULATION. THE FACILITY HAS TWO TYPES OF CONTROL MATERIAL FOR USE WITH THE I-STAT SYSTEM AND COULD NOT SPECIFY WHICH CONTROL WAS USED AT THE TIME. THE TWO TYPES OF CONTROL ARE DESCRIBED BELOW. THE CUSTOMER IDENTIFIED THE VIAL HAD A LEVEL NUMBER 3 ON THE LABEL. I-STAT CONTROL LEVELS 1,2,3-A BUFFERED AQUEOUS SOLUTION FOR IN VITRO DIAGNOSTIC USE FOR QUALITY CONTROL ON THE I-STAT SYSTEM. THE CONTROL SOLUTIONS DO NOT CONTAIN HUMAN SERUM OR SERUM PRODUCTS, BUT DO CONTAIN BUFFERS AND PRESERVATIVES. RNA MEDICAL HEMATOCRIT CONTROL LEVELS 1,2,3-A BUFFERED AQUEOUS SOLUTION CONTAINING ELECTROLYTES AND NON-CONDUCTIVE INGREDIENTS. THIS CONTROL SOLUTION CONTAINS NO RED BLOOD CELLS, NO HUMAN OR BIOLOGICAL MATERIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RNA MEDICAL HEMATOCRIT CONTROL LEVEL 3 CONTROL SOLUTION CGA BIONOSTICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other